FDA Drug recall D-0003-2022
Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydr…
- FDA Drug
- Class I
- terminated
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class I recall of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydr… by Azurity Pharmaceuticals, citing product Mix-up: Incorrect diluent component included in the kit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0003-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-08-24 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Azurity Pharmaceuticals |
| Distribution | US |
Product
Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.
Reason
Product Mix-up: Incorrect diluent component included in the kit.
Identifiers
| ndc | 65628-204-05 |
|---|---|
| ndc | 65628-205-10 |
| ndc | 65628-206-05 |
| ndc | 65628-208-10 |
| code_info | Lot # 21035, Exp 7/31/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0003-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.